Department of Biomedicine and Prevention, University of Rome "Tor Vergata", Via Montpellier 1, 00133, Rome, Italy.
Research and EBP Unit, Health Professions Department, Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42122, Reggio Emilia, Italy.
Support Care Cancer. 2022 Jul;30(7):6317-6325. doi: 10.1007/s00520-022-07073-8. Epub 2022 Apr 27.
Oral mucositis (OM) is one of the most debilitating effects of toxicity due to hematopoietic stem cell transplantation (HSCT) conditioning regimens. The aim of this secondary analysis of the data of a phase II study designed to assess the efficacy of a novel oral care protocol containing bovine colostrum and aloe vera to prevent oral mucositis was to compare outcomes reported by patients with those collected by healthcare professionals (HCPs).
Data on oral mucositis severity, duration, time of onset and related pain were collected from patients using the Oral Mucositis Daily Questionnaire (OMDQ). HCPs assessed the same outcomes using the World Health Organization oral mucositis scale and pain numerical rating scale. Quality of life was assessed with the 3-level EuroQol-5 dimensions.
Fifty-nine autologous/allogeneic graft patients were recruited, 46 of whom (78.0%) experienced OM. Mean onset was 9.1 (SD ± 3.5) days after conditioning initiation, mean duration was 10.4 (SD ± 4.3) days, and the average maximum pain score was 3.7 (SD ± 2.7). Self-administration of the OMDQ detected oral symptoms at least 1 day sooner compared to objective assessments (p = 0.025). Significant differences were observed between the patient-reported and the HCP-assessment data on oral mucositis severity grading distribution (p < 0.0001) and highest pain score (p < 0.0001). Quality of life score variations were correlated with changes in oral mucositis severity during patients' hospital stay.
Further studies are necessary to improve the understanding of these findings; a randomised controlled trial is being set up at our institution.
口腔黏膜炎（OM）是造血干细胞移植（HSCT）预处理方案引起的毒性中最具致残性的影响之一。本研究旨在评估一种新型口腔护理方案（含牛初乳和芦荟）预防口腔黏膜炎的疗效，该方案为一项 II 期研究的数据的二次分析，旨在比较患者报告的结果和医护人员（HCPs）收集的结果。
采用口腔黏膜炎每日问卷（OMDQ）收集患者口腔黏膜炎严重程度、持续时间、发病时间和相关疼痛的数据。HCPs 使用世界卫生组织口腔黏膜炎分级标准和疼痛数字评分量表评估相同的结果。采用 3 级欧洲五维健康量表评估生活质量。
共招募了 59 例自体/异基因移植患者，其中 46 例（78.0%）发生了 OM。发病平均时间为预处理开始后 9.1（SD±3.5）天，平均持续时间为 10.4（SD±4.3）天，平均最大疼痛评分为 3.7（SD±2.7）。与客观评估相比，患者自我管理的 OMDQ 至少提前 1 天发现口腔症状（p=0.025）。在口腔黏膜炎严重程度分级分布（p<0.0001）和最高疼痛评分（p<0.0001）方面，患者报告和 HCP 评估数据之间存在显著差异。患者住院期间口腔黏膜炎严重程度变化与生活质量评分变化相关。
需要进一步研究以深入了解这些发现；我们机构正在进行一项随机对照试验。
